Industrial GMP Peptide Synthesizer
Peptide & Purification

Industrial GMP Peptide Synthesizer

Industrial GMP Peptide Synthesizer Peptide & Purification — Mechotech

Industrial GMP Peptide Synthesizer

Mechotech designs and manufactures industrial single-channel solid-phase peptide synthesizers built for GMP peptide manufacturing at production scale. The system centres on a jacketed reaction tank — configurable from 10 L to 5000 L — in which the resin-bound peptide is assembled through precisely controlled, automated coupling, deprotection and wash cycles. Precise liquid dispensing, inert-gas pressure feed of reagents, jacketed temperature control and online flow metering on each solvent line give the repeatable, well-documented process that regulated peptide production demands. Available in EX-proof (EXD IIB T4 / IP65) or standard non-EX construction with local and remote control, the platform scales classical SPPS chemistry from clinical batches through to commercial active-pharmaceutical-ingredient manufacture.

A Mechotech industrial peptide synthesizer is engineered around a jacketed, agitated reaction tank served by metering pumps, inert-gas pressure feed and dedicated flow meters on every solvent and reagent line, so each addition is delivered accurately and recorded. Reagents are transferred under nitrogen pressure to keep the process inert and moisture-free, while the tank jacket holds coupling and deprotection steps at their set temperature for consistent reaction kinetics. Between steps a 360° clean-in-place (CIP) system flushes the vessel and internals to prevent carry-over and support cleaning validation, and both local touchscreen and remote supervisory control give operators full visibility of the batch. The unit is offered with an optional integrated cleavage module to release the peptide from the resin and remove side-chain protecting groups, closing the loop from assembly to crude peptide. Reactor volume, material of construction, hazardous-area rating and automation level are all specified to the customer's product, batch size and facility, and the 21 CFR Part 11 control software provides the audit trails and electronic records required for GMP.

Technical Specifications

TechnologyIndustrial single-channel solid-phase peptide synthesis (SPPS)
Synthesis Strategyt-Boc and Fmoc (configurable)
Reaction Tank Volume10 L to 5000 L (customizable)
Vessel TypeJacketed, agitated reaction tank
Reagent FeedInert-gas (nitrogen) pressure feed
Liquid DispensingPrecise metered dispensing per line
Flow MeasurementOnline flow meter on each solvent / reagent line
Temperature ControlJacketed heating / cooling (configurable range)
Cleaning360° clean-in-place (CIP)
Hazardous-Area RatingEX-proof EXD IIB T4 / IP65, or non-EX (configurable)
ControlLocal touchscreen and remote supervisory control
SoftwareFDA 21 CFR Part 11 compliant, with audit trail and e-records
Cleavage UnitOptional integrated module
Product-contact MaterialStainless steel 316L / chemically resistant lining

Plant Capacities

Reactor VolumeScale / UsageConstructionControlRating
10 LClinical / pilot batchesSS 316L jacketedLocal + remoteEX-proof or non-EX
20 LClinical / pilot batchesSS 316L jacketedLocal + remoteEX-proof or non-EX
50 LSmall GMP productionSS 316L jacketedLocal + remoteEX-proof or non-EX
100 LGMP productionSS 316L jacketedLocal + remoteEX-proof or non-EX
300 LGMP productionSS 316L jacketedLocal + remoteEX-proof or non-EX
500 LCommercial APISS 316L jacketedLocal + remoteEX-proof or non-EX
1000 LCommercial APISS 316L jacketedLocal + remoteEX-proof or non-EX
3000 LLarge-scale APISS 316L jacketedLocal + remoteEX-proof or non-EX
5000 LLarge-scale APISS 316L jacketedLocal + remoteEX-proof or non-EX

Reaction-tank sizes are fully customizable; the metering pumps, pressure-feed system, flow meters, CIP, temperature control, hazardous-area rating and optional cleavage unit are scaled to each reactor. Volumes shown are typical steps in the ladder — intermediate and larger custom sizes on request.

Manufacturing Process

1

Resin Charging & Swelling

Resin is loaded into the jacketed reaction tank and swelled in solvent under agitation, forming the support on which the peptide chain will be assembled.

2

Reagent Pressure Feed

Amino-acid, activator, deprotection and wash solutions are transferred under inert-gas pressure through metered lines, each monitored by an online flow meter.

3

Coupling

The activated amino acid is dosed into the vessel and mixed under jacketed temperature control, forming the amide bond under repeatable, inert conditions.

4

Solvent Washing

Programmed solvent washes flush excess reagents and by-products from the resin bed, with drained volumes tracked by the flow-metering system.

5

Deprotection

The temporary N-terminal protecting group is removed under controlled temperature and time so the amine is ready for the next coupling cycle.

6

Cycle Repetition

Coupling, washing and deprotection repeat for every residue in the sequence under recipe control, with each step logged for full batch traceability.

7

360° Clean-in-Place

The integrated CIP system spray-cleans the vessel and internals between batches to prevent cross-contamination and support cleaning validation.

8

Cleavage (Optional Module)

The optional cleavage unit releases the peptide from the resin and removes side-chain protection, delivering crude peptide ready for downstream purification.

Applications

  • GMP manufacture of peptide active pharmaceutical ingredients (APIs)
  • Clinical-batch and commercial-scale peptide production
  • Peptide therapeutics and hormone analogues
  • Peptide-based vaccine antigens at production scale
  • Cosmetic and nutraceutical peptide manufacturing
  • Contract development and manufacturing (CDMO) peptide services
  • Scale-up of validated research sequences to kilo-scale batches
  • Diagnostic and reference-standard peptide production

Key Features

  • Scalable 10 L–5000 L Reactor

    A jacketed reaction tank configurable from 10 L to 5000 L takes classical SPPS chemistry from clinical batches to commercial API manufacture.

  • Inert-Gas Pressure Feed & Flow Metering

    Reagents are fed under nitrogen pressure with an online flow meter on each solvent line for accurate, inert, fully documented additions.

  • Jacketed Temperature Control

    The tank jacket holds coupling and deprotection steps at set temperature for consistent reaction kinetics and reproducible batches.

  • 360° Clean-in-Place

    An integrated CIP system spray-cleans the vessel and internals between batches to prevent carry-over and support cleaning validation.

  • EX-Proof or Non-EX Options

    Available in hazardous-area EX-proof construction (EXD IIB T4 / IP65) or standard non-EX build, with local touchscreen and remote control.

  • Optional Integrated Cleavage Unit

    An optional cleavage module releases the peptide from the resin and removes side-chain protection, delivering crude peptide in-line.

Frequently Asked Questions

What is an industrial peptide synthesizer?
It is a production-scale solid-phase peptide synthesis system built around a jacketed reaction tank rather than small lab vessels. It automates the coupling, deprotection and wash cycles at batch volumes suitable for GMP manufacturing of peptide active pharmaceutical ingredients, with the metering, cleaning and documentation that regulated production requires.
What reactor sizes are available?
The reaction tank is configurable from 10 L up to 5000 L, covering clinical and pilot batches through to commercial API manufacture. Sizes are fully customizable, and the pumps, pressure feed, flow meters, CIP and temperature control are all scaled to the chosen reactor volume.
Is the system suitable for GMP manufacturing?
Yes. It combines precise metered dispensing, inert-gas pressure feed, jacketed temperature control, 360° clean-in-place and 21 CFR Part 11 compliant control software with audit trails and electronic records, so batches are reproducible, documented and ready for cleaning validation.
Can it be used in a hazardous area?
The synthesizer is offered in EX-proof construction rated EXD IIB T4 / IP65 for flammable-solvent environments, or in a standard non-EX build where area classification allows. Both are available with local touchscreen and remote supervisory control.
Does it include cleavage of the peptide from the resin?
An optional integrated cleavage module is available that releases the peptide from the resin and removes side-chain protecting groups, delivering crude peptide in-line and ready for downstream purification such as prep-HPLC.
How is the vessel cleaned between batches?
A 360° clean-in-place (CIP) system spray-cleans the reaction tank and internals between batches. This minimises manual intervention, prevents cross-contamination between products and supports the cleaning-validation requirements of GMP manufacturing.
Does Mechotech supply it turnkey?
Yes. Mechotech delivers the industrial peptide synthesizer as a complete engineered system — reactor, fluidics, CIP, controls, hazardous-area rating and optional cleavage unit — with design, manufacture, installation, commissioning and after-sales support, configured to the customer's product and facility.

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